e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 29, 2008
Or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-27598
IRIDEX CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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77-0210467 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification Number) |
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1212 Terra Bella Avenue |
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Mountain View, California
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94043-1824 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (650) 940-4700
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes o No þ
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller
reporting company
in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company) |
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
APPLICABLE ONLY TO CORPORATE ISSUERS:
The number of shares
of common stock, $.01 par value, issued and outstanding as of May 9, 2008 was
8,824,301
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudited)
IRIDEX Corporation
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
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Mar 29, |
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Dec 29, |
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2008 |
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2007 (1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
4,013 |
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$ |
5,809 |
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Restricted cash |
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3,800 |
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Accounts receivable, net |
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8,440 |
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8,876 |
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Inventories, net |
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16,013 |
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15,967 |
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Prepaids and other current assets |
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1,095 |
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1,051 |
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Total current assets |
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29,561 |
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35,503 |
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Property and equipment, net |
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1,481 |
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1,621 |
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Goodwill |
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3,239 |
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3,239 |
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Other intangible assets, net |
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5,358 |
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5,944 |
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Other long term assets |
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282 |
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347 |
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Total assets |
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$ |
39,921 |
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$ |
46,654 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
4,404 |
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$ |
2,887 |
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Bank line of credit |
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5,281 |
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4,863 |
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Accrued compensation |
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1,567 |
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2,024 |
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Accrued expenses |
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6,005 |
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7,809 |
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Accrued warranty |
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1,500 |
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1,895 |
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Deferred revenue |
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3,254 |
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3,350 |
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Bank term loan current portion |
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5,016 |
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Total current liabilities |
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22,011 |
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27,844 |
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Commitments and contingencies |
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Stockholders equity: |
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Convertible Preferred Stock, $.01 par value: |
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Authorized: 2,000,000 shares; |
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Issued and outstanding: 500,000 shares in 2008 and 2007 |
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5 |
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5 |
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Common Stock, $.01 par value: |
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Authorized: 30,000,000 shares; |
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Issued and outstanding: 8,824,301 shares in 2008 and 2007 |
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89 |
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89 |
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Additional paid-in capital |
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38,727 |
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38,695 |
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Accumulated other comprehensive loss |
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(128 |
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(88 |
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Treasury stock, at cost |
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(430 |
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(430 |
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(Accumulated deficit) retained earnings |
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(20,353 |
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(19,461 |
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Total stockholders equity |
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17,910 |
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18,810 |
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Total liabilities and stockholders equity |
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$ |
39,921 |
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$ |
46,654 |
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(1) |
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Derived from the consolidated audited financial statements included in our
report filed on Form 10-K with the SEC for the year ended December 29,
2007. |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
IRIDEX Corporation
Condensed Consolidated Statements of Operations
(Unaudited, in thousands except per share data)
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Three Months Ended |
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Mar 29, |
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Mar 31, |
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2008 |
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2007 |
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Revenues |
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$ |
11,474 |
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$ |
12,566 |
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Cost of goods sold |
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6,669 |
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7,357 |
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Gross profit |
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4,805 |
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5,209 |
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Operating expenses: |
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Research and development |
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1,025 |
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1,729 |
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Selling, general and administrative |
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4,518 |
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8,274 |
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Total operating expenses |
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5,543 |
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10,003 |
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Loss from operations |
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(738 |
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(4,794 |
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Interest and other (expense) income, net |
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(154 |
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(126 |
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Loss before income taxes |
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(892 |
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(4,920 |
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Benefit from (provision for) income taxes |
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Net loss |
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$ |
(892 |
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$ |
(4,920 |
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Net loss per share basic and diluted |
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$ |
(0.10 |
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$ |
(0.61 |
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Shares used in computing net loss per
share basic and diluted |
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8,824 |
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8,080 |
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Condensed Consolidated Statements of Comprehensive Loss
(Unaudited, in thousands)
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Three Months Ended |
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Mar 29, |
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Mar 31, |
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2008 |
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2007 |
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Net Loss |
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$ |
(892 |
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(4,920 |
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Foreign currency translation adjustments |
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(128 |
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(9 |
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Comprehensive Loss |
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$ |
(1,020 |
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$ |
(4,929 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
IRIDEX Corporation
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
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Three Months Ended |
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Mar 29, |
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Mar 31, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(892 |
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$ |
(4,920 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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823 |
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802 |
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Stock compensation recognized |
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32 |
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356 |
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Provision for doubtful accounts |
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29 |
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Provision for inventories |
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(45 |
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285 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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408 |
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1,687 |
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Inventories |
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(2 |
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(1,327 |
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Prepaids and other current assets |
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(45 |
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36 |
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Other long term assets |
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65 |
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(71 |
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Accounts payable |
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1,517 |
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3,602 |
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Accrued compensation |
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(457 |
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Accrued expenses |
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(1,804 |
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880 |
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Accrued warranty |
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(395 |
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(543 |
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Deferred revenue |
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(96 |
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393 |
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Net cash (used in) provided by operating activities |
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(862 |
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1,180 |
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Cash flows from investing activities: |
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Business acquisition cost |
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(24,166 |
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Purchases of property and equipment |
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(96 |
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(217 |
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Net cash used in investing activities |
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(96 |
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(24,383 |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock |
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672 |
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Proceeds of credit facility, net of issuance costs |
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5,281 |
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11,900 |
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Restricted cash balance offset against credit facility |
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3,800 |
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Repayment of credit facility |
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(9,879 |
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(863 |
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Net cash (used in) provided by financing activities |
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(798 |
) |
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11,709 |
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Effect of foreign exchange rate changes |
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(40 |
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11 |
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Net decrease in cash and cash equivalents |
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(1,796 |
) |
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(11,483 |
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Cash and cash equivalents at beginning of period |
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5,809 |
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21,051 |
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Cash and cash equivalents at end of period |
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$ |
4,013 |
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$ |
9,568 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
IRIDEX Corporation
Notes to Unaudited Condensed Consolidated Financial Statements
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of IRIDEX Corporation
(the Company) have been prepared in accordance with generally accepted accounting principles in
the United States for interim financial information and pursuant to the instructions to Form 10-Q
and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted in the United States for complete
financial statements. In the opinion of management, all adjustments, consisting of normal recurring
adjustments, considered necessary for a fair statement of the financial statements have been
included.
The condensed consolidated financial statements should be read in conjunction with the audited
financial statements and notes thereto, together with managements discussion and analysis of
financial condition and results of operations, contained in our Annual Report on Form 10-K, which
was filed with the Securities and Exchange Commission on April 10, 2008. The independent
accountants report included a qualification paragraph that stated the Companys losses from
operations and failure to meet certain debt covenants raised substantial doubt about the Companys
ability to continue as a going concern. The results of operations for the three month period ended
March 29, 2008 are not necessarily indicative of the results for the year ending January 3rd, 2009
or any future interim period.
As of December 29, 2007 the Company was out of compliance with its debt covenants on its
existing credit facilities with Mid-Peninsula Bank and the Export-Import Bank (the Lenders).
However, the Company obtained a waiver for the default and in March 2008 the Company terminated the
credit facilities and entered into a new credit facility with Wells Fargo Bank which provides the
Company with the ability to borrow up to $8 million under an asset-based revolving credit facility.
Management believes that the new facility with Wells Fargo Bank provides sufficient liquidity
to operate for the next 12 months and that the covenants are reasonable and management expects to
be able to meet those covenants based on its operating plan for 2008. However, recent operating
results indicate that there is significant risk in achieving the operating plan, particularly for
the remaining period where the Company is obligated to make payments to American Medical Systems,
Inc refer to Note 6 below. If the Company is not able to perform in accordance with its operating
plan for 2008 and fails to maintain compliance with its debt covenants, Wells Fargo Bank would be
entitled to exercise its remedies under this facility which include declaring all outstanding
obligations due and payable, and disposing of the collateral if obligations are not paid.
These matters raise substantial doubt about the Companys ability to continue as a going
concern. The accompanying financial statements do not include any adjustments that might result
from the outcome of this uncertainty. The Companys financial statements have been prepared on a
going concern basis which contemplates the realization of assets and the settlement of liabilities
and commitments in the normal course of business.
Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No 141(R) (revised 2007), Business Combinations (SFAS
141R), which replaces SFAS 141. SFAS 141R establishes principles and requirements for how an
acquirer recognizes and measures in its financial statements the identifiable assets acquired, the
liabilities assumed and the goodwill acquired. SFAS 141R also establishes disclosure requirements
that will enable users to evaluate the nature and financial effects of the business combination.
SFAS 141R is effective as of the beginning of an entitys fiscal year that begins after December
15, 2008 and will be adopted by the Company in the first quarter of fiscal year 2009. While the
Company expects that SFAS 141R will have an impact on accounting for business combinations once
adopted, the effect is dependent upon acquisitions at that time.
In December 2007, the FASB issued SFAS 160, Noncontrolling Interests in Consolidated
Financial Statements, an amendment of ARB No. 51 (SFAS 160). The standard changes the accounting
for noncontrolling (minority) interests in consolidated financial statements including the
requirements to classify noncontrolling interests as a component of consolidated stockholders
equity, and the elimination of minority interest accounting in results of operations with
earnings
6
attributable to noncontrolling interests reported as part of consolidated earnings.
Additionally, SFAS 160 revises the accounting for both increases and decreases in a parents
controlling ownership interest. SFAS 160 is effective for fiscal years beginning after December 15,
2008, with early adoption prohibited. The Company believes it is unlikely that the adoption of SFAS
160 will have an impact on the consolidated financial statements because the Company does not hold
a noncontrolling (minority) interest in another entity.
On March 19, 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, an amendment of FASB Statement No. 133 (SFAS No. 161). SFAS No. 161 requires
enhanced disclosures about an entitys derivative and hedging activities. These enhanced
disclosures will discuss (a) how and why an entity uses derivative instruments, (b) how derivative
instruments and related hedged items are accounted for under Statement 133 and its related
interpretations, and (c) how derivative instruments and related hedged items affect an entitys
financial position, financial performance, and cash flows. SFAS No. 161 is effective for financial
statements issued for fiscal years and interim periods beginning after November 15, 2008. We have
not determined the impact, if any SFAS No. 161 will have on our consolidated financial statements.
Recently Adopted Accounting Standards
In September 2006, the FASB issued SFAS 157, Fair Value Measurements, which defines fair
value, establishes a framework for measuring fair value in accordance with generally accepted
accounting principles, and expands disclosures about fair value measurements. SFAS 157 is effective
January 1, 2008. The Company does not believe the adoption of SFAS 157 will have a material impact
on the consolidated financial statements. SFAS No. 157 is effective for financial statements issued
for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years,
with early adoption permitted, except for the impact of FASB Staff Position (FSP) 157-2. FSP 157-2
deferred the adoption of SFAS 157 for non financial assets and liabilities until years ended after
November 15, 2008. On January 1, 2008 we adopted SFAS 157 for financial assets and liabilities.
Carrying amounts of our financial instruments including cash and cash equivalents, accounts
receivables, accounts payables and accrued liabilities approximate fair value due to their short
maturities. The fair value of bank line of credit approximates fair value due to its floating rate
nature.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and
Financial Liabilities. SFAS 159 was issued to allow entities to voluntarily choose to measure
certain financial assets and liabilities at fair value (fair value option). The fair value option
may be elected on an instrument-by-instrument basis and is irrevocable, unless a new election date
occurs. If the fair value option is elected for an instrument, SFAS 159 specifies that unrealized
gains and losses for that instrument shall be reported in earnings at each subsequent reporting
date. SFAS 159 is effective January 1, 2008. On January 1, 2008 we adopted SFAS 159 and have made
no election under SFAS 159.
2. Summary of Significant Accounting Policies
The Companys significant accounting policies are disclosed in our Annual Report on Form 10-K
for the year ended December 29, 2007 which was filed with the Securities and Exchange Commission on
April 10, 2008.
Valuation of Goodwill and Intangible Assets.
The purchase method of accounting for acquisitions requires estimates and assumptions to
allocate the purchase price to the fair value of net tangible and intangible assets acquired. The
amounts allocated to, and the useful lives estimated for, intangible assets, affect future
amortization. There are a number of generally accepted valuation methods used to estimate fair
value of intangible assets, and we use primarily a discounted cash flow method, which requires
significant management judgment to forecast the future operating results and to estimate the
discount factors used in the analysis. Purchased intangible assets were initially recorded in the
first quarter of 2007 in conjunction with the acquisition of the aesthetics business of Laserscope.
We review our intangible assets for impairment whenever events or changes in circumstances indicate
that their carrying value may not be recoverable. An asset is considered impaired if its carrying
amount exceeds the future net cash flow the asset is expected to generate. If an asset is
considered to be impaired, the impairment to be recognized is measured by the amount by which the
carrying amount of the asset exceeds its fair value. During the first three quarters of 2007 we did
not identify any events that indicated that there had been an impairment in the carrying value of
these intangible assets. In the fourth quarter of 2007 the Company determined that based on
estimated future cash flows the carrying amount of specific intangible assets exceeded their fair
value; accordingly an impairment loss was recognized.
7
Goodwill and intangible assets determined to have indefinite lives are not amortized, but are
subject to an annual impairment test. To determine any goodwill impairment, a two-step process is
performed on an annual basis, or more frequently if necessary, to determine 1) whether the fair
value of the relevant reporting unit exceeds carrying value and 2) to measure the amount of an
impairment loss, if any. Goodwill was initially recorded in the first quarter of 2007 in
conjunction with the acquisition of the aesthetics business of Laserscope. During the first three
quarters of 2007, we did not identify any events that indicated that there had been an impairment in the carrying value of goodwill. In the fourth
quarter the Company performed an annual impairment test. We identified the Laserscope Aesthetics
reporting unit as the appropriate reporting unit for this analysis. Reporting units are operating
segments or components of operating segments for which discrete financial information is available.
The conclusion was that the carrying value of the reporting unit exceeded the fair value. As a
result, management performed the second step and determined the fair value of the assets and
liabilities of the reporting unit to measure the amount of impairment loss. By establishing the
fair value of the reporting unit and the fair value of assets and liabilities within the reporting
unit, the Company determined the amount of impairment to goodwill.
Future changes in events or circumstances, such as an inability to achieve the cash flows
determined above, may indicate that the recorded value of the intangible assets will not be
recovered through future cash flows, or if the fair value of the Laserscope Aesthetics business
unit is determined to be less than its carrying value, the Company may be required to record an
additional impairment charge for the intangible assets or goodwill or further modify the period of
expected lives for the intangible assets.
Revenue Recognition.
Our revenues arise from the sale of laser consoles, delivery devices, disposables and service
and support activities. Revenue from product sales is recognized upon receipt of a purchase order
and product shipment provided that no significant obligations remain and collection of the
receivables is reasonably assured. Shipments are generally made with Free-On-Board (FOB) shipping
point terms, whereby title passes upon shipment from our dock. Any shipments with FOB receiving
point terms are recorded as revenue when the shipment arrives at the receiving point. Cost is
recognized as product sales revenue is recognized. Our Companys sales may include post-sales
obligations for training or other deliverables. When these obligations are fulfilled after product
shipment, the Company recognizes revenue in accordance with the multiple element accounting
guidance set forth in Emerging Issues Task Force No. 00-21, Revenue Arrangements with Multiple
Deliverables. When the Company has objective and reliable evidence of fair value of the
undelivered elements, it defers revenue attributable to the post-sale obligations and recognizes
such revenue when the obligation is fulfilled. Otherwise, the Company defers all revenue related to
the transaction until all elements are delivered. Revenue relating to extended warranty contracts
is recognized on a straight line basis over the period of the applicable warranty contract. We
recognize repair service revenue upon completion of the work.
In international regions outside of the UK and France, we utilize distributors to market and
sell our products. We recognize revenue upon shipment for sales through these independent, third
party distributors as we have no continuing obligations subsequent to shipment. Generally our
distributors are responsible for all marketing, sales, installation, training and warranty labor
coverage for our products. Our standard terms and conditions do not provide price protection or
stock retention rights to any of our distributors.
Deferred Revenue
Revenue related to extended service contracts is deferred and recognized on a straight line
basis over the period of the applicable service period. Costs associated with these service
arrangements are recognized as incurred. A reconciliation of the changes in the Companys deferred
revenue balance for the three months ending March 29, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Mar 29, |
|
|
Mar 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Balance, beginning of period |
|
$ |
3,350 |
|
|
$ |
1,415 |
|
Additions to deferral through acquisition |
|
|
|
|
|
|
1,870 |
|
Additions to deferral |
|
|
1,750 |
|
|
|
1,976 |
|
Revenue recognize |
|
|
(1,846 |
) |
|
|
(1,576 |
) |
|
|
|
|
|
|
|
Balance, end of period |
|
$ |
3,254 |
|
|
$ |
3,685 |
|
|
|
|
|
|
|
|
8
Warranty
The Company accrues for estimated warranty cost upon shipment of products. Actual warranty
costs incurred have not materially differed from those accrued. The Companys warranty policy is
applicable to products which are considered defective in their performance or fail to meet the
product specifications. Warranty costs are reflected in the statement of operations as a cost of
sales. A reconciliation of the changes in the Companys warranty liability for the three months
ending March 29, 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Mar 29, |
|
|
Mar 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Balance, beginning of period |
|
$ |
1,895 |
|
|
$ |
866 |
|
Warranty accrual acquired through acquisition |
|
|
|
|
|
|
1,771 |
|
Accrual for warranties issued during the period |
|
|
57 |
|
|
|
356 |
|
Settlements made in kind during the period |
|
|
(452 |
) |
|
|
(657 |
) |
|
|
|
|
|
|
|
Balance, end of period |
|
$ |
1,500 |
|
|
$ |
2,336 |
|
|
|
|
|
|
|
|
3. Business Combination
On January 16, 2007, the Company acquired the aesthetics business of American Medical Systems,
Inc. (AMS) and Laserscope, a wholly owned subsidiary of AMS for $28.6 million including the direct
costs of acquisition for cash and 213,435 shares of common stock valued at $9.43 per share. These
financial statements include the results of operations for the acquired business from the
acquisition date. The Company made the acquisition due to its complementary fit with the existing
IRIDEX aesthetics laser business. At the time of the acquisition the Company recorded Goodwill of
$10.1 million and intangible assets of $16.4 million. At the end of 2007 the Company conducted an
impairment test in accordance with SFAS 142 Goodwill and Other Intangible Assets and determined
that based on operating results for 2007 and the outlook for the aesthetics business for 2008 and
beyond, there was significant impairment to the intangible assets and goodwill. In addition, the
Company revisited the useful lives associated with the remaining intangible assets to ensure they
reflected the revised outlook for the aesthetics business. The impact of this review was to write
down goodwill by $6.9 million from $10.1 million to $3.2 million and write down the gross carrying
value of the intangible assets by $7.8 million from $16.4 million to $8.6 million. The net carrying
value of intangible assets after impairment, in aggregate, which includes the amortization expense for the year as
of December 29, 2007 was $5.9 million and as of March 29, 2008
was $5.4 million
Amortization of intangible assets associated with the acquisition was $586,000 and $606,000
for the three months ended March 29, 2008 and March 31, 2007, respectively.
4. Inventories
The components of the Companys inventories are as follows:
|
|
|
|
|
|
|
|
|
|
|
Mar 29, |
|
|
Dec 29, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Raw materials and work in progress |
|
$ |
9,474 |
|
|
$ |
9,450 |
|
Finished goods |
|
|
6,539 |
|
|
|
6,517 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
16,013 |
|
|
$ |
15,967 |
|
|
|
|
|
|
|
|
5. Bank Borrowings
On January 16, 2007, the Company entered into (i) a Business Loan and Security Agreement (the
Business Loan Agreement) with Mid-Peninsula Bank, part of Greater Bay Bank N.A. (the Lenders), (ii)
an Export-Import Bank Loan and Security Agreement (the Exim Agreement) with the Lenders, and (iii)
a Borrower Agreement (the Borrower Agreement and together with the Business Loan Agreement and the
Exim Agreement, the Credit Agreement) in favor of the Lenders and Export-Import Bank of the United
States (Exim Bank). The Credit Agreement provided for an asset-based revolving line of credit of up
to $6 million (the Revolving Loans) and a $6 million term loan (the Term Loan). Of the Revolving
Loans, up to $3 million principal amount (the Exim Sublimit) was guaranteed by Exim Bank. The
Companys obligations under the Term Loans and the Revolving Loans (including the Exim Sublimit)
were secured by a lien on substantially all of the Companys
9
assets. Interest on the Term Loan and
the Revolving Loans (including the Exim Sublimit) was the prime rate as published in the Wall
Street Journal, minus 0.5%, subject to adjustment under certain circumstances including adjustments
to the prime rate, late payment or the occurrence of an event of default. Payments of principal outstanding under the
Term Loan were due in sixty monthly installments beginning February 28, 2007 and ending February
28, 2012. All outstanding amounts under the Revolving Loans were payable in full on January 31,
2009. If at any time the amount outstanding under the Revolving Loans exceeded the Borrowing Base
as defined in the Credit Agreement the Company was required to pay the difference between the
outstanding amount and the Borrowing Base. The Company was able to prepay all amounts outstanding
under the Term Loan and Revolving Loans without penalty. These facilities contained certain
financial and other covenants, including the requirement for the Company to maintain profitability
on a quarterly basis, tangible net worth of $15.5 million, maintain unrestricted cash/marketable
securities of $3 million and maintain a debt service ratio of 1.75 to 1.00 on an annual basis. In
addition, the Company must maintain $3 million in unrestricted cash in an account with the Lenders.
Other covenants included, but were not limited to, restricting the Companys ability to incur
indebtedness, incur liens, enter into mergers or consolidations, dispose of assets, make
investments, pay dividends, enter into transactions with affiliates, or prepay certain
indebtedness. In the event of noncompliance by the Company with the covenants under these
facilities, Mid-Peninsula Bank and Export-Import Bank, were entitled to exercise their remedies,
which included declaring all obligations immediately due and payable and disposing of the
collateral if obligations were not paid.
As of December 29, 2007 the Company was out of compliance with its debt covenants on its
existing credit facilities with the Lenders. Subsequent to the year end the Company obtained a
waiver for the default.
On March 28, 2008, the Company terminated the Credit Agreement with the Lenders repaying all
outstanding balances and entered into (i) a Borrowing Agreement and (ii) an Export-Import Bank Loan
and Security Agreement with Wells Fargo Bank (together referred to as the Agreement). The Agreement
provides for an asset-based revolving line of credit of up to $8 million (the New Revolving Loans).
Of the New Revolving Loans, up to $5 million principal amount (the New Exim Sublimit) will be
guaranteed by Exim Bank. The Companys obligations under the New Revolving Loans (including the New
Exim Sublimit) are secured by a lien on substantially all of the Companys assets. Interest on the
New Revolving Loans (including the New Exim Sublimit) is the prime rate as published in the Wall
Street Journal, plus 0.75%, subject to adjustment under certain circumstances including adjustments
to the prime rate, late payment or the occurrence of an event of default. All outstanding amounts
under the New Revolving Loans are payable in full on March 27, 2011. If at any time the amount
outstanding under the New Revolving Loans exceeds the Borrowing Base as defined in the Agreement,
the Company will be required to pay the difference between the outstanding amount and the Borrowing
Base. The Company may prepay New Revolving Loans without penalty. These facilities contain certain
financial and other covenants, including the requirement for the Company to maintain a certain
level of net income (loss) and to be able to sufficiently cover its debt service needs. Other
covenants include, but are not limited to, restricting the Companys ability to incur indebtedness,
incur liens, enter into mergers or consolidations, dispose of assets, make investments, pay
dividends, enter into transactions with affiliates, or prepay certain indebtedness. In the event of
noncompliance by the Company with the covenants under this Agreement, Wells Fargo Bank and
Export-Import Bank, would be entitled to exercise their remedies, which include declaring all
obligations immediately due and payable and disposing of the collateral if obligations are not
paid.
6. AMS Settlement
On August 14, 2007, the Company, AMS and Laserscope (collectively the Parties), entered into a
Settlement Agreement (the Settlement Agreement). The Parties entered into the Settlement Agreement
to document their full and final agreement as to the amount of the adjustment contemplated by
Section 1.5 of the Asset Purchase Agreement, by and among the Parties, dated November 30, 2006 (the
Purchase Agreement); to amend the Product Supply Agreement, between Laserscope and the Company,
dated January 16, 2007 (the Product Supply Agreement); and to set forth the Parties mutual
understanding as to certain other matters.
The Settlement Agreement provides that, pursuant to Section 1.5 of the Purchase Agreement, the
Company will make an additional payment to AMS of approximately $1.2 million, which will be the
sole and final adjustment to the purchase price and will be paid in equal weekly installments of
$22,115 beginning August 16, 2007 over the course of the next year. This $1.2 million amount
reflects the net amount owed by the Company to AMS after taking into account the $3.9 million in
cash obtained through the Companys acquisition of Laserscopes foreign subsidiaries, which was not
included in the original purchase price, net of $2.7 million owed to the Company by AMS pursuant to
the purchase price adjustment provisions of the Purchase Agreement.
10
In addition, the Settlement Agreement modifies and amends certain terms of the Product Supply
Agreement, including among others: (a) agreement upon the current and future products to be built
and delivered by Laserscope to the Company and the payment terms relating thereto; (b) allocation of and pricing and delivery terms relating
to inventory parts to be sold by Laserscope to the Company and (c) agreement upon certain payments
to be made by the Company to AMS in the event that the Company increases its borrowing capacity to
more than $12,000,000 under any credit facility that is senior to the Companys payment obligations
under the Settlement Agreement. Under the terms of the Settlement Agreement, the Company agreed to
payments totaling $4,059,557 in respect of certain inventory and service parts to be purchased from
AMS following termination of the Product Supply Agreement. This sum is to be paid in 39 weekly
installments of $110,185 which includes an interest charge of 10% per annum beginning on January 3,
2008. This sum is in settlement of potential payments of up to $9 million for inventory from AMS
following the scheduled termination of the Product Supply Agreement in October 2007.
The total unpaid balance, not including interest to be paid, relating to the Settlement
Agreement of $3.1 million and $4.8 million is included in accrued liabilities as of March 29, 2008
and December 29, 2007, respectively. In addition, as of March 29, 2007 the Company has outstanding
non-cancelable purchase orders placed with AMS to purchase in aggregate an additional $824,000 of
inventory to be delivered monthly ending in September 2008.
The parties have also agreed subject to certain limitations, to release each other from any
claims related to indemnification, purchase price and post-closing adjustments in the Purchase
Agreement as well as any amounts due under the Product Supply Agreement. The Company also agreed to
release AMS and Laserscope from any liability from claims related to the sections in the Purchase
Agreement dealing with financial matters, undisclosed liabilities, receivables and preparation of
historical financial statements. The Parties agreed that, other than with respect to fraud and
certain specified representations and warranties, the representations and warranties contained in
the Purchase Agreement terminated contemporaneously with the signing of the Settlement Agreement
and the Parties could no longer make indemnification claims relating thereto.
Upon execution of the Settlement Agreement, the Company also executed a Security Agreement,
dated August 14, 2007 (the Security Agreement), granting AMS and Laserscope a subordinate security
interest in all the Companys assets to secure all of its current and future obligations to AMS or
Laserscope.
Any breach by the Company of any provision of any of its agreements with AMS or Laserscope
shall constitute an immediate default and shall entitle AMS and Laserscope to any and all remedies
available to them under the Security Agreement, the Product Supply Agreement, and the Settlement
Agreement, including, but not limited to, the right to terminate the Product Supply Agreement
immediately upon written notice to the Company with no additional notice period or opportunity to
cure and the right to declare all amounts due from the Company to AMS to be immediately due and
payable in full.
7. Stock Based Compensation
For the three months ended March 29, 2008 the Company had one active stock plan: The 1998
Stock Plan, which expired in February 2008. The terms and awards granted during the three months
ended March 29, 2008 were consistent with those described in our December 29, 2007 annual
consolidated financial statements.
The following table summarizes information regarding activity in our stock option plans during
the three months ended March 29, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Exercise Price |
|
|
Remaining Contractual |
|
|
Aggregate |
|
|
|
Number of Shares |
|
|
Per Share |
|
|
Life (Years) |
|
|
Intrinsic Value |
|
Outstanding at Dec 29, 2007 |
|
|
1,859,537 |
|
|
$ |
6.09 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
383,812 |
|
|
|
3.04 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled or forfeited |
|
|
(229,151 |
) |
|
|
6.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at Mar 29, 2008 |
|
|
2,014,198 |
|
|
$ |
5.50 |
|
|
|
4.44 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and
expected to vest at Mar 29, 2008 |
|
|
1,844,196 |
|
|
$ |
5.51 |
|
|
|
4.29 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at Mar 29, 2008 |
|
|
1,322,500 |
|
|
$ |
5.70 |
|
|
|
3.55 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
The aggregate intrinsic value in the table above represents the pre-tax intrinsic value, based
on the Companys closing price as of March 29, 2008, that would have been received by option
holders had all options holders exercised their stock options as of that date. During the three
months ended March 29, 2008 the intrinsic value of options exercised was $0.
The weighted-average grant fair value of the options granted under the Companys stock plans
was $1.96 and $5.21 per share for the three months ended March 29, 2008 and March 31, 2007,
respectively.
The Company uses the Black-Scholes option-pricing model to estimate fair value of stock-based
awards with the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Mar 29, 2008 |
|
Mar 31, 2007 |
Average risk free interest rate |
|
|
3.25 |
% |
|
|
4.50 |
% |
Expected life (in years) |
|
6 years |
|
4.61 years |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Average volatility |
|
|
70.0 |
% |
|
|
59.0 |
% |
Option-pricing models require the input of various subjective assumptions, including the
options expected life and the price volatility of the underlying stock. The expected stock price
volatility is based on analysis of the Companys stock price history over a period commensurate
with the expected term of the options, trading volume of the Companys stock, look-back
volatilities and Company specific events that affected volatility in a prior period. The Company
has elected to use the simplified method for estimating the expected term as discussed in SAB No.
107 and SAB No. 110. The risk-free interest rate is based on the U.S. Treasury interest rates whose
term is consistent with the expected life of the stock options. No dividend yield is included as
the Company has not issued any dividends and does not anticipate issuing any dividends in the
future.
The following table shows stock-based compensation expense included in the Consolidated
Statements of Operations for the three months periods ended March 29, 2008 and March 31, 2007 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Mar 29, 2008 |
|
|
Mar 31, 2007 |
|
Cost of sales |
|
$ |
23 |
|
|
$ |
26 |
|
Research and development |
|
|
30 |
|
|
|
62 |
|
Sales, general and administrative |
|
|
(21 |
) |
|
|
268 |
|
|
|
|
|
|
|
|
|
|
$ |
32 |
|
|
$ |
356 |
|
|
|
|
|
|
|
|
8. Stock Option Exchange Offer
On February 22, 2008, the Company offered (the Exchange Offer) to eligible employees to
exchange all of their outstanding restricted common stock for new options to be granted under the
1998 Plan. The Exchange Offer covered 21,000 shares of restricted common stock granted to employees
on February 13, 2007. The exchange ratio was 1.5 to one.
The Exchange Offer expired on February 22, 2008, at which time properly tendered restricted
common stock for 21,000 shares were cancelled and new options for 31,500 shares were granted at the
closing price of our common stock on the grant date. The fair value of modified awards granted
approximated the fair value of the original awards cancelled.
All new options have an option expiration term of 7 years. Each new option has a four year
vesting period, 1/48th of the shares subject to the option shall vest one month after
the grant date and 1/48th of the shares subject to the option will vest each month
thereafter.
9. Computation of Basic and Diluted Net Loss Per Common Share
Basic and diluted net loss per share are computed by dividing net loss for the period by the
weighted average number of shares of common stock outstanding during the period. Because there is a
loss the calculation of diluted net loss per share does not include common stock equivalents
because the effect would be anti-dilutive. Common stock equivalents consist of incremental common
shares issuable upon the exercise of stock options and the conversion of Preferred A stock into
common shares.
During the three months ended March 29, 2008, options to purchase 2,014,198 shares of common
stock at a weighted average exercise price of $5.50 as well as 1,000,000 shares of common shares
issuable on the conversion of 500,000 Preferred A stock which will automatically convert into
common shares in the event the common stock of the Company trades at or
12
above $5.00 per share for a
period of 30 consecutive trading days, have not been included in the computation of diluted net
loss per common share because their effect is anti-dilutive. These shares could dilute earnings per
share in future periods.
During the three months ended March 31, 2007, options to purchase 2,306,529 shares at a
weighted average exercise price of $6.55 have not been included in the computations of diluted net
loss per common share because their effect was anti-dilutive.
10. Business Segments
The Company operates in two reportable segments: the ophthalmology segment and the aesthetics
segment. In each segment the Company develops, manufactures, and markets medical devices. Our
revenues arise from the sale of consoles, delivery devices, disposables and service and support
activities.
Information on reportable segments for the three months ended March 29, 2008 and March 31,
2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended Mar 29, 2008 |
|
|
Three Months Ended Mar 31, 2007 |
|
(in thousands) |
|
Ophthalmology |
|
|
Aesthetics |
|
|
Total |
|
|
Ophthalmology |
|
|
Aesthetics |
|
|
Total |
|
Revenues |
|
$ |
7,536 |
|
|
$ |
3,938 |
|
|
$ |
11,474 |
|
|
$ |
7,189 |
|
|
$ |
5,377 |
|
|
$ |
12,566 |
|
Direct cost of goods sold |
|
|
2,069 |
|
|
|
1,653 |
|
|
|
3,722 |
|
|
|
2,144 |
|
|
|
2,835 |
|
|
|
4,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct gross profit |
|
|
5,467 |
|
|
|
2,285 |
|
|
|
7,752 |
|
|
|
5,045 |
|
|
|
2,542 |
|
|
|
7,587 |
|
Total
unallocated indirect costs |
|
|
|
|
|
|
|
|
|
|
( 8,644 |
) |
|
|
|
|
|
|
|
|
|
|
(12,507 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax loss |
|
|
|
|
|
|
|
|
|
$ |
(892 |
) |
|
|
|
|
|
|
|
|
|
$ |
(4,920 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct cost of goods sold includes standard product cost (direct material, labor and fringe) and
any warranty and unit royalty due. Indirect costs of manufacturing, research and development,
marketing and selling, and general and administrative costs are not allocated to the segments. The
Companys assets and liabilities are not evaluated on a segment basis. Accordingly, no disclosure
of segment assets and liabilities is provided.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains trend analysis and other forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, such as statements relating to levels of
future sales and operating results; broadening our product line through product innovation; market
acceptance of our products; expectations for future sales growth, generally, including expectations
of additional sales from our new products and new applications of our existing products; our
ability to integrate the newly acquired aesthetics business into our core business successfully and
in a timely manner; the potential for production cost decreases and higher gross margins; our
ability to develop and introduce new products through strategic alliances; our ability to reduce
spending, including a reduction in the use of contractors and consultants; levels of interest
income and expense; expectations regarding our effective tax rate; continued receipt of payments
from the Synergetics Settlement; general economic conditions; levels of international sales; our
current liquidity, ability to obtain additional financing, and meet the covenants of our existing
financing agreement with Wells Fargo, and impact of concern regarding our ability to generate
sufficient cash flow to continue as a going concern; and the potential to record an impairment
charge to goodwill and intangible assets and effects of recent accounting pronouncements on our
financial position; effect of pending or known to be threatened litigation on operating results;
our ability to protect our proprietary information. In some cases, forward-looking statements can
be identified by terminology, such as may, will, should, expects, plans, anticipates,
believes, estimates, predicts, intends, potential, continue, or the negative of such
terms or other comparable terminology. These statements involve known and unknown risks,
uncertainties and other factors which may cause our actual results, performance or achievements to
differ materially from those expressed or implied by such forward-looking statements, including as
a result of the factors set forth under Factors That May Affect Future Operating Results and
other risks detailed in our Annual Report on Form 10-K filed with the Securities and Exchange
Commission on April 10, 2008 and detailed from time to time in our reports filed with the
Securities and Exchange Commission. The reader is cautioned not to place undue reliance on these
forward-looking statements, which reflect managements analysis only as of the date of this
quarterly report on Form 10-Q. We undertake no obligation to update such forward-looking statements
to reflect events or circumstances occurring after the date of this report.
Overview
IRIDEX Corporation is a leading worldwide provider of therapeutic based laser systems and
delivery devices used to treat eye diseases in ophthalmology and skin conditions in aesthetics. In
January 2007, the Company acquired Laserscopes aesthetics business including its subsidiaries in
France and the United Kingdom (UK) from American Medical Systems Holdings (AMS). Our aesthetics
treatments encompass minimally invasive surgical treatments for pigmented and vascular lesions,
skin rejuvenation, skin tightening, hair reduction, leg veins, and acne.
Our products are sold in the United States (US) predominantly through a direct sales force and
internationally through approximately 100 independent distributors into 107 countries except for
our aesthetics products which are sold, marketed and serviced directly in the UK and France.
We manage and evaluate our business in two segments ophthalmology and aesthetics. We further
break down these segments by geography Domestic (US) and International (the rest of the world).
In addition, within ophthalmology, we review trends by laser system sales (consoles and delivery
devices) and recurring sales (single use disposable laser probes (disposables), service and
support).
Our ophthalmology revenues arise primarily from the sale of our IRIS Medical OcuLight and IQ
810 laser systems, disposables and revenues from service and support activities. Our current family
of OcuLight systems includes the OcuLight TX, the OcuLight Symphony (Laser Delivery System),
OcuLight SL, OcuLight SLx, OcuLight GL and OcuLight GLx laser photocoagulation systems as well as
the IRIS Medical IQ 810 laser system. We also produce the Millennium Endolase module which is sold
exclusively to Bausch & Lomb and incorporated into their Millennium Microsurgical System.
Our aesthetics revenues arise primarily from the sales of our aesthetics including: the
Gemini, Venus-i, Lyra-i and Aura-i Laser Systems, the VersaStat 10 mm, VersaStat-i, and Dermastat
handpieces along with an articulated arm for the Venus-i Laser System, as well as our VariLIte and
DioLite XP laser systems.
Sales to international distributors are made on open credit terms or letters of credit and are
currently denominated in United States dollars and, accordingly, are not subject to risks
associated with international monetary conditions and currency
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fluctuations. Sales of aesthetics products to end customers from our UK and French
subsidiaries are denominated in British pounds and Euros, respectively.
Cost of goods sold consists primarily of the cost of purchasing components and sub-systems,
assembling, packaging, shipping and testing components at our facility, direct labor and associated
overhead and, beginning in 2007, amortization of intangible assets acquired in the Laserscope
acquisition, and the addition of the field service organization in the US in support of the
Laserscope aesthetics products.
Research and development expenses consist primarily of personnel costs, materials to support
new product development and research support provided to clinicians at medical institutions
developing new applications which utilize our products. Research and development costs have been
expensed as incurred.
Sales, general and administrative expenses consist primarily of costs of personnel, sales
commissions, travel expenses, advertising and promotional expenses, facilities cost, legal and
accounting fees, insurance and other expenses not allocated to other departments.
Results of Operations
The following table sets forth certain operating data as a percentage of sales for the periods
included.
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Three Months Ended |
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Mar 29, 2008 |
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Mar 31, 2007 |
Revenues |
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100.0 |
% |
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100.0 |
% |
Cost of goods sold |
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58.1 |
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58.5 |
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Gross Margin |
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41.9 |
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41.5 |
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Operating expenses: |
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Research and development |
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8.9 |
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13.8 |
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Selling, general and administrative |
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39.4 |
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65.8 |
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Total operating expenses |
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48.3 |
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79.6 |
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Loss from operations |
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(6.4 |
) |
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(38.1 |
) |
Interest and other (expense) income, net |
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(1.4 |
) |
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(1.0 |
) |
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Loss before income tax |
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(7.8 |
) |
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(39.1 |
) |
Provision for income taxes |
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0.0 |
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0.0 |
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Net loss |
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(7.8 |
) |
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(39.1 |
) |
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Revenues.
Total revenue decreased by 8.7% to $11.5 million for the three months ended March 29, 2008
from $12.6 million for the three months ended March 31, 2007.
Ophthalmology revenues in total increased $0.3 million or 4.8%: with domestic ophthalmology
system revenues increasing $0.3 million to $1.2 million and international ophthalmology system
revenues decreasing $0.2 million to $1.8 million. Ophthalmology recurring revenues consisting of
disposables and service increased $0.2 million and represented 55.2% of our aggregate ophthalmology
business in the three months ended March 29, 2008 compared to 55.5% for the three months ended
March 31, 2007. Revenues from OEMs remained constant at $0.4 million for the comparable periods.
Aesthetics revenues in total decreased $1.4 million or (26.8%) to $3.9 million: with
international aesthetics system revenues decreasing $0.5 million to $1.9 million, domestic
aesthetics system revenues decreasing $1.3 million to $0.2 million and service revenues increasing
$0.3 million to $1.8 million. The decrease in our aesthetics revenues is primarily due to the
difficulties incurred in the US distribution channel during 2007 that are still being experienced
coupled with the overall softening of the US aesthetics market.
Gross Profit.
Gross profit decreased to $4.8 million for the three months ended March 29, 2008 from $5.2
million for the three months ended March 31, 2007. The decrease in gross profit was primarily the
result of decreased revenues as gross margins remained comparable between periods.
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Gross margin represented 41.9% of revenues for the three months ended March 29, 2008 and 41.5%
of revenues for the three months ended March 31, 2007.
Gross margins as a percentage of sales will continue to fluctuate due to changes in the
relative proportions of domestic and international sales, the product mix of sales, costs
associated with future product introductions and total unit volume changes that lead to greater or
lesser production efficiencies and a variety of other factors. See Item 1A. Risk Factors Factors
That May Affect Future Results Our Operating Results May Fluctuate from Quarter to Quarter and
Year to Year.
Research and Development.
Research and development includes primarily salary costs and costs of materials for projects
associated with research and product development. Research and Development expenses decreased by
40.7% to $1.0 million from $1.7 million for the three months ended March 29, 2008 compared to the
three months ended March 31, 2007. The primary reason for this was reduced salary and related costs
resulting from the reduction in headcount from period to period and reduced material costs incurred
on product development. In the future we expect to target our level of research and development
spending at approximately 10% of our revenues to maintain a consistent level of new product
introductions.
Sales, General and Administrative.
Sales, general and administrative expense decreased in the three months ended March 29, 2008
by 45.4% to $4.5 million from $8.3 million for the three months ended March 31, 2007. Selling
expenses decreased $1.3 million due to lower salary and related costs due to reduced headcount and
lower commissions as a result of lower sales for the comparable periods. Marketing expense
decreased $0.9 million primarily due to lower salary and related costs due to reduced headcount and
reduced spending on aesthetics related marketing programs. General and administrative expenses
decreased $1.8 million primarily due to reduced legal and accounting fees of $1.2 million. The
legal fees incurred in the three months ended March 31, 2007 were in support of litigation which
has been resolved and the accounting fees incurred in Q1 2007 were in support of the acquisition.
Stock compensation for the three months ended March 29, 2008 and March 31, 2007 was $32,000 and
$356,000, respectively. The reduction in stock compensation expense in the three months ended March
29, 2008 was the result of a true up adjustment for forfeited options required by SFAS 123R
Share-Based Payment.
Interest and Other expense, net.
Interest and Other expense consist of $0.2 million and $0.1 million of interest expense for
the three months ending March 29, 2008 and March 31, 2007, respectively. The interest expense
relates to the bank debt outstanding in the respective periods offset by interest earned on cash
deposits.
Income Taxes.
Significant components affecting the effective tax rate include pre-tax net loss, changes in
valuation allowance, federal and state R&D tax credits, income from tax-exempt securities, the
state composite tax rate and recognition of certain deferred tax assets subject to valuation
allowance. For the three month periods ending March 29, 2008 and March 31, 2007 no tax provision
was recorded.
Liquidity and Capital Resources.
Liquidity is our ability to generate sufficient cash flows from operating activities to meet
our obligations and commitments. In addition, liquidity includes the ability to obtain appropriate
financing or to raise capital.
As of March 29, 2008 we had cash and cash equivalents of $4.0 million and working capital of
$7.6 million. The Company used $0.9 million in operations in the three months ended March 29, 2008
which included repaying $1.7 million of the outstanding liability to AMS. Our remaining contractual
obligations to AMS amount to $3.1 million plus interest and $0.8 million of unconditional purchase
orders relating to future deliveries See Note 6 of Notes to Consolidated Financial Statements in
this report for more information regarding the AMS Settlement.
As of December 29, 2007 the Company was out of compliance with its debt covenants on its
existing credit facilities with Mid-Peninsula Bank and the Export-Import Bank (the Lenders).
Subsequent to the year end the Company obtained a waiver of
the debt covenants with which we were not compliant. In March 2008 the Company terminated the
credit facilities and entered
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into a new credit facility with Wells Fargo Bank which provides the
Company with the ability to borrow up to $8 million under an asset-based revolving credit facility
See Note 5 of Notes to Consolidated Financial Statements in this report for more information
regarding the new credit facility.
The credit facility that existed at December 29, 2007 consisted of a term loan and an asset
based revolving credit facility. The amounts outstanding at year end under the term loan and
revolving credit facility were $5 million and $4.9 million, respectively. In March 2008 the Company
repaid the amounts then outstanding under these facilities using the $3.8 million of restricted
cash and borrowing $5.3 million against the new asset based revolving credit facility.
Management is of the opinion that the new credit facility with Wells Fargo Bank provides
sufficient liquidity to operate for the next 12 months; that the covenants contained in the new
credit facility with Wells Fargo Bank are reasonable; and management expects to be able to meet
these covenants based on its operating plan for 2008. However, recent operating results indicate
that there is significant risk in achieving the operating plan, particularly for the remaining
period where the Company is obligated to make payments to AMS. If the Company is not able to
perform according to the Companys operating plan for 2008 and is unable to maintain compliance
with its debt covenants, Wells Fargo Bank would be entitled to exercise its remedies which include
declaring all outstanding obligations due and payable, and disposing of the collateral if
obligations are not paid.
Item 3. Quantitative and Qualitative Disclosure about Market Risk
Market risk represents the risk of loss that may impact the financial position, results of
operations or cash flows due to adverse changes in financial and commodity market prices and rates.
We transact the majority of our business in US dollars and therefore changes in foreign currency
rates will not have a significant impact on our income statement or cash flows. However, increases
in the value of the US dollar against any local currencies could cause our products to become
relatively more expensive to customers in a particular country or region, leading to reduced
revenue or profitability in that country or region. As we continue to expand our international
sales, our non-US dollar denominated revenue and our exposure to gains and losses on international
currency transactions may increase. In January 2007 we acquired two European subsidiaries as part
of our acquisition of the assets of the aesthetics business of Laserscope. These entities do
transact business in their geographies in their local currency. We currently do not engage in
transactions to hedge against the risk of the currency fluctuation, but we may do so in the future.
Item 4T. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Our management evaluated, with the participation of its Chief Executive Officer (CEO) and its
Chief Financial Officer (CFO), the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Rule 13A-15(e) and Rule 15d-15(e) of the Securities Exchange
Act of 1934 (the 34 Act), as of the end of the period covered by this report.
Disclosure controls and procedures are designed with the objective of ensuring that (i)
information required to be disclosed in our reports filed under the 34 Act is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms and (ii)
information is accumulated and communicated to management, including the CEO and CFO, as
appropriate to allow timely decisions regarding required disclosure. Internal control procedures,
which are designed with the objective of providing reasonable assurance that our transactions are
properly authorized, recorded and reported, and our assets are safeguarded against unauthorized or
improper use, are intended to permit the preparation of our financial statements in conformity with
generally accepted accounting principles. To the extent that elements of our internal controls over
financial reporting are included within our disclosure controls and procedures, they are included
in the scope of our quarterly controls evaluation.
Based on that evaluation, and as a result of the material weakness in our internal controls
over financial reporting discussed below, the CEO and CFO concluded that as of the end of the
period covered by this report, the Companys disclosure controls and procedures were not effective.
A material weakness is a control deficiency, or a combination of control deficiencies, that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. Management determined that the staffing
levels in the finance function are inadequate and that this represented a control
deficiency in the operation of our internal controls and processes over financial reporting
that they considered to be a material
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weakness at March 29, 2008, because the control deficiency
resulted in more than a remote likelihood that a material misstatement could occur in our quarterly
financial statements and not be prevented or detected.
During the three months ended March 29, 2008 the Company enhanced the current resources of the
Companys finance function by adding a new Chief Financial Officer and an additional staff member
and has plans to add another staff member during fiscal 2008. The Company anticipates that these
additional resources will remediate the material weakness described above during the course of
fiscal 2008.
Even if we are to successfully remediate the material weakness described above, because of
inherent limitations, our disclosure controls and procedures may not prevent or detect
misstatements or material omissions. Projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
(b) Changes in Internal Controls
There were no changes in our internal controls over financial reporting that occurred during
the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Management believes that claims which are pending or known to be threatened, will not have a
material adverse effect on the Companys financial position or results of operations and are
adequately covered by the Companys liability insurance. However, it is possible that cash flows or
results of operations could be materially affected in any particular period by the unfavorable
resolution of one or more of these contingencies or because of the diversion of managements
attention and the incurrence of significant expenses.
Item 1A. Risk Factors
Factors That May Affect Future Results
In addition to the other information contained in this Quarterly Report Form 10-Q, we have
identified the following risks and uncertainties that may have a material adverse effect on our
business, financial condition, common stock price, or results of operation. You should carefully
consider the risks described below before making an investment decision.
We believe there is significant risk as to whether our current liquidity and capital resources
will be sufficient to meet our currently planned operating requirements for the next 12 months.
As of December 29, 2007, the Company was out of compliance with its debt covenants on its
existing credit facilities with Mid-Peninsula Bank and the Export-Import Bank (the Lenders). We
have obtained a waiver of the debt covenants of which we were not in compliance from the Lenders
subsequent to December 29, 2007. In March 2008 the Company replaced these credit facilities with a
new facility with Wells Fargo Bank (the Bank). The new facility is an asset based revolving loan
facility that allows the Company to borrow up to $8 million if sufficient collateral is available.
Collateral is defined as certain accounts receivable balances and certain eligible inventory items
that form the borrowing base against which the Company may borrow. The facility also specifies a
number of covenants including two that are financial: a monthly net income / loss target and
monthly debt service coverage target. Although management is of the opinion that this facility
provides sufficient liquidity to operate for the next 12 months, that the covenants are reasonable
and management expects to be able to meet these covenants, recent operating results indicate that
there is significant risk in achieving these goals, particularly for the remaining period where we
are obligated to make payments to AMS. If the Company is not able to perform and becomes out of
compliance with its debt covenants, the Bank would be entitled to exercise its remedies under the
new credit facility which include declaring all outstanding obligations due.
Our independent registered public accounting firm, Burr, Pilger, & Mayer LLP, issued an
opinion in connection with their audit of our financial statements for the fiscal year ended
December 29, 2007 which stated, that there was substantial doubt as to our ability to continue as a
going concern.
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We Have More Indebtedness and Fewer Liquid Resources After the Acquisition of the Aesthetics
Business of Laserscope, Which Does Adversely Affect Our Cash Flows and Business.
In order to complete the Laserscope acquisition, we entered into financing arrangements and
used the majority of our liquid resources. Previously we had no debt outstanding. In addition, as
of March 29, 2008, we had a remaining obligation to AMS of $3.1 million plus interest and
outstanding non cancelable purchase orders to purchase an additional $0.8 million of inventory from
AMS. The increased levels of debt and obligations do among other things:
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require us to dedicate a substantial portion of our cash flow from operations to
payments on our debt and obligations, thereby reducing funds available for working capital,
capital expenditures, acquisitions and other purposes; |
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make it more difficult for us to meet our payments and other obligations to other 3rd
parties; |
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increase our vulnerability to, and limit our flexibility in planning for, adverse
economic and industry conditions; |
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increase our sensitivity to interest rate increases on our indebtedness with variable
interest rates; |
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result in an event of default if we fail to comply with the financial and other
restrictive covenants contained in our debt agreements, which event of default could result
in all of our debt becoming immediately due and payable; |
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affect our credit rating; |
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limit our ability to obtain additional financing to fund future working capital,
capital expenditures, additional acquisitions and other general corporate requirements; |
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create competitive disadvantages compared to other companies with less indebtedness;
and |
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limit our ability to apply proceeds from an offering or asset sale to purposes other
than the repayment of debt. |
The Company May Not Realize The Anticipated Benefits of Our Acquisition of the Aesthetics
Business of Laserscope.
On January 16, 2007, we completed our acquisition of the aesthetics business of Laserscope
(the Aesthetics Business), a wholly-owned subsidiary of American Medical Systems Holdings, Inc.
To date, we have not realized the anticipated benefits of the acquisition and our ability to
realize the anticipated benefits of the acquisition will depend, in part, on our ability to
integrate the Aesthetics Business with our business and to take full advantage of the domestic and
international sales channels. For example, immediately following the completion of the acquisition
the domestic sales force consisted of 28 sales representatives and managers. On December 29, 2007
there were six sales representatives and managers in the domestic aesthetics sales force.
Integrating the Aesthetics Business has been expensive and time-consuming and we may not be able to
successfully complete the process. These integration efforts have taken a significant amount of
time, placed a significant strain on managerial, operational and financial resources and proven to
be more difficult and more expensive than predicted. The diversion of our managements attention
and any delays and difficulties encountered in connection with integrating the Aesthetics Business
could continue to result in the disruption of our on-going business or inconsistencies in
standards, controls, procedures and policies that could negatively affect our ability to maintain
relationships with customers, suppliers, collaborators, employees and others with whom we have
business dealings. These disruptions could harm our operating results.
We cannot assure you that the combination of the Aesthetics Business with us will result in
the realization of the full benefits anticipated from the acquisition.
If There is Not Sufficient Demand for the Aesthetics Procedures Performed with Our Products,
Practitioner Demand for Our Products Could be Inhibited, Resulting in Unfavorable Operating Results
and Reduced Growth Potential.
Continued expansion of the global market for laser- and other light-based aesthetics
procedures is a material assumption of our growth strategy. Most procedures performed using our
aesthetics products are elective procedures not reimbursable through government or private health
insurance, with the costs borne by the patient. The decision to utilize our aesthetics products may
therefore be influenced by a number of factors, including:
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evolving customer needs; |
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the introduction of new products and technologies; |
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evolving surgical practices; |
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evolving industry standards; |
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the cost of procedures performed using our products; |
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the cost, safety and effectiveness of alternative treatments, including treatments
which are not based upon laser- or other light-based technologies and treatments which use
pharmaceutical products; |
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the success of our sales and marketing efforts; and |
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consumer confidence, which may be impacted by economic and political conditions. |
If, as a result of these factors, there is not sufficient demand for the procedures performed
with our aesthetics products, practitioner demand for our aesthetics products could be reduced,
resulting in unfavorable operating results and lower growth potential.
Failure to Remediate the Material Weaknesses in Our Disclosure Controls and Procedures in a
Timely Manner, or at All, Could Harm Our Operating Results or Cause Us to Fail to Meet Our
Regulatory or Reporting Obligations.
We evaluated the effectiveness of our disclosure controls and procedures as of the end of the
period covered by this report and, based on this evaluation, management concluded that our
disclosure controls and procedures were not effective because of the material weaknesses detailed
in Item 4T of Part I of this Quarterly Report on Form 10-Q.
In particular, the material weaknesses identified related to the Companys staffing levels
that impacted our ability to implement the remediation plan designed to address the material
weakness identified in last years Annual Report concerning period-end review procedures. We are
taking a number steps designed to remedy the material weaknesses summarized above, including hiring
a Chief Financial Officer and other staff members of the finance function. However, if despite our
remediation efforts, we fail to remediate our material weaknesses, we could be subject to
regulatory scrutiny and a loss of public confidence in our disclosure controls and procedures.
These remediation efforts will likely increase our general and administrative expenses and could,
therefore, have an adverse effect on our reported net income.
Even if we are to successfully remediate such material weaknesses, because of inherent
limitations, our disclosure controls and procedures may not prevent or detect misstatements or
material omissions. Projections of any evaluation of effectiveness to future periods are subject to
the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
We Rely on Continued Market Acceptance of Our Existing Products and Any Decline in Sales of
Our Existing Products Would Adversely Affect Our Business and Results of Operations.
We currently market visible and infrared medical laser systems and delivery devices to the
ophthalmology and aesthetics markets. We believe that continued and increased sales, if any, of
these medical laser systems is dependent upon a number of factors including the following:
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acceptance of product performance, features, ease of use, scalability and durability; |
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recommendations and opinions by ophthalmologists, dermatologists, plastic surgeons,
other clinicians, and their associated opinion leaders; |
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clinical study outcomes; |
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price of our products and prices of competing products and technologies; |
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availability of competing products, technologies and alternative treatments; and |
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level of reimbursement for treatments administered with our products. |
In addition, we derive a meaningful portion of our sales from recurring revenues including
disposable laser probes, EndoProbes and service. Our ability to increase recurring revenues from
the sale of laser probes will depend primarily upon the features of our current products and
product innovation, ease of use and prices of our products, including the relationship to prices of
competing delivery devices. The level of our service revenues will depend on the quality of service
we provide and the responsiveness and the willingness of our customers to request our services
rather than purchase competing products or services. Any significant decline in market acceptance
of our products or our revenues derived from the sales of laser consoles, delivery devices or
services may have a material adverse effect on our business, results of operations and financial
condition.
Our Future Success Depends on Our Ability to Develop and Successfully Introduce New Products
and New Applications.
Our future success is dependent upon, among other factors, our ability to develop, obtain
regulatory approval or clearance of, manufacture and market new products. Successful
commercialization of new products and new applications will require that we effectively transfer
production processes from research and development to manufacturing and effectively coordinate with
our suppliers. In addition, we must successfully sell and achieve market acceptance of new products
and applications and enhanced versions of existing products. The extent of, and rate at which,
market acceptance and penetration are achieved by future products is a function of many variables,
which include, among other things, price, safety, efficacy, reliability, marketing and sales
efforts, the development of new applications for these products, the availability of third-party
reimbursement of procedures using our new products, the existence of competing products and general
economic conditions affecting purchasing patterns. Our ability to market and sell new products may
also be subject to government regulation, including approval or clearance by the United States Food
and Drug Administration, or FDA, and foreign government agencies. Any failure in our ability to
successfully develop and introduce new products or enhanced versions of existing products and
achieve market acceptance of new products and new applications could have a material adverse effect
on our operating results and would cause our net revenues to decline.
While We Devote Significant Resources to Research and Development, Our Research and
Development May Not Lead to New Products that Achieve Commercial Success.
The Companys ability to generate incremental revenue growth will depend, in part, on the
successful outcome of research and development activities, including clinical trials, that lead to
the development of new products and new applications using our products. Our research and
development process is expensive, prolonged, and entails considerable uncertainty. Because of the
complexities and uncertainties associated with ophthalmic and aesthetics research and development,
products we are currently developing may not complete the development process or obtain the
regulatory approvals required to market such products successfully. The products currently in our
development pipeline may not be approved by regulatory entities and may not be commercially
successful, and our current and planned products could be surpassed by more effective or advanced
products of current or future competitors. Therefore, even if we are able to successfully develop
enhancements or new generations of our products, these enhancements or new generations of products
may not produce revenue in excess of the costs of development and they may be quickly rendered
obsolete by changing customer preferences or the introduction by our competitors of products
embodying new technologies or features.
The Clinical Trial Process Required to Obtain Regulatory Approvals is Costly and Uncertain,
and Could Result in Delays in New Product Introductions or Even an Inability to Release a Product.
The clinical trials required to obtain regulatory approvals for our products are complex and
expensive and their outcomes are uncertain. We incur substantial expense for, and devote
significant time to, clinical trials but cannot be certain that the trials will ever result in the
commercial sale of a product. We may suffer significant setbacks in clinical trials, even after
earlier clinical trials showed promising results. Any of our products may produce undesirable side
effects that could cause us or regulatory authorities to interrupt, delay or halt clinical trials
of a product candidate. We, the FDA, or another regulatory authority may suspend or terminate
clinical trials at any time if they or we believe the trial participants face unacceptable health
risks.
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We Face Strong Competition in Our Markets and Expect the Level of Competition to Grow in the
Foreseeable Future.
Competition in the market for devices used for ophthalmic and aesthetics treatment procedures
is intense and is expected to increase. Our competitive position depends on a number of factors
including product performance, characteristics and functionality, ease of use, scalability,
durability and cost. Our principal competitors in ophthalmology are Lumenis Ltd., Nidek Co. Ltd,
Carl Zeiss Meditec AG, Ellex Medical Lasers Ltd, Alcon Inc., and Synergetics. Most of these
companies currently offer a competitive, semiconductor-based laser system for ophthalmology. Also
within ophthalmology, pharmaceutical alternative treatments for AMD such as Lucentis/Avastin
(Genentech), and to a lesser extent Visudyne (Novartis) and Macugen (OSI Pharmaceuticals) compete
rigorously with traditional laser procedures.
In aesthetics our principal competitors are Syneron, Candela Corporation, Palomar
Technologies, Inc., Cutera, Lumenis Ltd and Cynosure. These competitors have more sales
representatives supporting broader product lines. Some competitors have substantially greater
financial, engineering, product development, manufacturing, marketing and technical resources than
we do.
In both markets, some companies also have greater name recognition than we do and
long-standing customer relationships. In addition to other companies that manufacture
photocoagulators, we compete with pharmaceuticals, other technologies and other surgical
techniques. Some medical companies, academic and research institutions, or others, may develop new
technologies or therapies that are more effective in treating conditions targeted by us or are less
expensive than our current or future products. Any such developments could have a material adverse
effect on our business, financial condition and results of operations.
If We Cannot Increase Our Sales Volumes, Reduce Our Costs or Introduce Higher Margin Products
to Offset Anticipated Reductions in the Average Unit Price of Our Products, Our Operating Results
May Suffer.
The average unit price of our products may decrease in the future in response to changes in
product mix, competitive pricing pressures, new product introductions by our competitors or other
factors. If we are unable to offset the anticipated decrease in our average selling prices by
increasing our sales volumes or through new product introductions, our net revenues will decline.
In addition, to maintain our gross margins we must continue to reduce the manufacturing cost of our
products. If we cannot maintain our gross margins our business could be seriously harmed,
particularly if the average selling price of our products decreases significantly without a
corresponding increase in sales.
We Rely on Patents and Proprietary Rights to Protect our Intellectual Property and Business.
Our success and ability to compete is dependent in part upon our proprietary information. We
rely on a combination of patents, trade secrets, copyright and trademark laws, nondisclosure and
other contractual agreements and technical measures to protect our intellectual property rights. We
file patent applications to protect technology, inventions and improvements that are significant to
the development of our business. We have been issued sixteen United States patents and five foreign
patents on the technologies related to our products and processes. We have approximately seven
pending patent applications in the United States and five foreign pending patent applications that
have been filed. Our patent applications may not be approved. Along with the acquisition of the
AMS/Laserscope aesthetic products, we acquired a royalty-free license to eleven of the
AMS/Laserscope patents. In addition, we acquired a license to a Palomar patent under which
royalties are paid to Palomar based upon a percentage of sales of certain products acquired from
AMS/Laserscope. Any patents granted now or in the future may offer only limited protection against
potential infringement and development by our competitors of competing products. Moreover, our
competitors, many of which have substantial resources and have made substantial investments in
competing technologies, may seek to apply for and obtain patents that will prevent, limit or
interfere with our ability to make, use or sell our products either in the United States or in
international markets.
Patents have a limited lifetime and once a patent expires competition may increase. For
example our Connector Patent used to connect our delivery devices (disposable & non-disposable)
to our laser consoles will expire in 2009. Delivery devices which do not utilize our Connector
Patent technology are not recognized by our laser consoles. We derive, and expect to continue to
derive, a large portion of our recurring revenue and profits from sales of our disposable laser
probe products. Expiration of this patent may increase competition from our competitors for our disposable
laser probe business and there can be no guarantees that we will maintain our market share of this
business.
In addition to patents, we rely on trade secrets and proprietary know-how which we seek to
protect, in part, through proprietary information agreements with employees, consultants and other
parties. Our proprietary information agreements with our employees and consultants contain industry
standard provisions requiring such individuals to assign to us without additional consideration any
inventions conceived or reduced to practice by them while employed or retained by us, subject to
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customary exceptions. Proprietary information agreements with employees, consultants and others may
be breached, and we may not have adequate remedies for any breach. Also, our trade secrets may
become known to or independently developed by competitors.
The laser and medical device industry is characterized by frequent litigation regarding patent
and other intellectual property rights. Companies in the medical device industry have employed
intellectual property litigation to gain a competitive advantage. Numerous patents are held by
others, including academic institutions and our competitors. Until recently patent applications
were maintained in secrecy in the United States until the patents issued. Patent applications filed
in the United States after November 2000 generally will be published eighteen months after the
filing date. However, since patent applications continue to be maintained in secrecy for at least
some period of time, both within the United States and with regards to international patent
applications, we cannot assure you that our technology does not infringe any patents or patent
applications held by third parties. We have, from time to time, been notified of, or have otherwise
been made aware of, claims that we may be infringing upon patents or other proprietary intellectual
property owned by others. If it appears necessary or desirable, we may seek licenses under such
patents or proprietary intellectual property. Although patent holders commonly offer such licenses,
licenses under such patents or intellectual property may not be offered or the terms of any offered
licenses may not be reasonable.
Any claims, with or without merit, and regardless of whether we are successful on the merits,
would be time-consuming, result in costly litigation and diversion of technical and management
personnel, cause shipment delays or require us to develop non-infringing technology or to enter
into royalty or licensing agreements. For example, during fiscal year 2007, the Company settled
patent litigations with Synergetics, Inc., which was time-consuming, costly and a diversion of
technical and management personnel. An adverse determination in a judicial or administrative
proceeding and failure to obtain necessary licenses or develop alternate technologies could prevent
us from manufacturing and selling our products, which would have a material adverse effect on our
business, results of operations and financial condition.
We Depend on International Sales for a Significant Portion of Our Operating Results.
We derive, and expect to continue to derive, a large portion of our revenue from international
sales. For the quarter ended March 29, 2008, our international sales were $5.6 million or 48.4% of
total sales. We anticipate that international sales will continue to account for a significant
portion of our revenues, particularly ophthalmology, in the foreseeable future. None of our
international revenues and costs has been denominated in foreign currencies, other than sales made
by our UK and French subsidiaries. As a result, an increase in the value of the U.S. dollar
relative to foreign currencies makes our products more expensive and thus less competitive in
foreign markets. The factors stated above could have a material adverse effect on our business,
financial condition or results of operations. Our international operations and sales are subject to
a number of other risks and potential costs, including:
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differing local product preferences and product requirements; |
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cultural differences; |
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changes in foreign medical reimbursement and coverage policies and programs; |
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political and economic instability; |
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impact of recessions in economies outside of the United States; |
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difficulty in staffing and managing foreign operations; |
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performance of our international channel of distributors; |
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foreign certification requirements, including continued ability to use the CE mark in
Europe; |
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reduced or limited protections of intellectual property rights in jurisdictions outside
the United States; |
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longer accounts receivable collection periods; |
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fluctuations in foreign currency exchange rates; |
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potentially adverse tax consequences; and |
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multiple protectionist, adverse and changing foreign governmental laws and regulations. |
Any one or more of these factors stated above could have a material adverse effect on our
business, financial condition or results of operations.
As we expand our existing international operations, especially following our acquisition of
the aesthetics business of Laserscope, we may encounter new risks. For example, as we focus on
building our international sales and distribution networks in new geographic regions, we must
continue to develop relationships with qualified local distributors and trading companies. If we
are not successful in developing these relationships, we may not be able to grow sales in these
geographic regions. These or other similar risks could adversely affect our revenue and
profitability.
We Are Exposed to Risks Associated With Worldwide Economic Slowdowns and Related
Uncertainties.
Concerns about consumer and investor confidence, volatile corporate profits and reduced
capital spending, international conflicts, terrorist and military activity, civil unrest and
pandemic illness could cause a slowdown in customer orders or cause customer order cancellations.
In addition, political and social turmoil related to international conflicts and terrorist acts may
put further pressure on economic conditions in the United States and abroad. Unstable political,
social and economic conditions make it difficult for our customers, our suppliers and us to
accurately forecast and plan future business activities. In particular, it is difficult to develop
and implement strategy, sustainable business models and efficient operations, as well as
effectively manage supply chain relationships. If such conditions persist, our business, financial
condition and results of operations could suffer.
We Rely on Our Direct Sales Force and Network of International Distributors to Sell Our
Products and any Failure to Maintain Our Direct Sales Force and Distributor Relationships Could
Harm Our Business.
Our ability to sell our products and generate revenue depends upon our direct sales force
within the United States and relationships with independent distributors outside the United States.
Currently our direct sales force consists of 21 employees and we maintain relationships with
approximately 100 independent distributors internationally selling our products into 107 countries.
We generally grant our distributors exclusive territories for the sale of our products in specified
countries. The amount and timing of resources dedicated by our distributors to the sales of our
products is not within our control. Our international sales are entirely dependent on the efforts
of these third parties. If any distributor breaches terms of its distribution agreement or fails to
generate sales of our products, we may be forced to replace the distributor and our ability to sell
our products into that exclusive sales territory would be adversely affected.
We do not have any long-term employment contracts with the members of our direct sales force.
We may be unable to replace our direct sales force personnel with individuals of equivalent
technical expertise and qualifications, which may limit our revenues and our ability to maintain
market share. The loss of the services of these key personnel would harm our business. Similarly,
our distributor agreements are generally terminable at will by either party and distributors may
terminate their relationships with us, which would affect our international sales and results of
operations.
If We Lose Key Personnel or Fail to Integrate Replacement Personnel Successfully, Our Ability
to Manage Our Business Could Be Impaired.
Our future success depends upon the continued service of our key management, technical, sales,
and other critical personnel. Our officers and other key personnel are employees-at-will, and we
cannot assure you that we will be able to retain them. Key personnel have left our Company in the
past and there likely will be additional departures of key personnel from time to time in the
future. On October 16, 2007, Barry G. Caldwell resigned as the Companys President and Chief
Executive Officer and as a member of the Companys Board of Directors, effective as of that date. Upon Mr.
Caldwells resignation, Theodore A. Boutacoff, the Companys current Chairman of the Board,
returned to serve as President and Chief Executive Officer. Mr. Boutacoff was the Companys
President and Director from 1989 until 2005. On July 20, 2007, Meryl A. Rains resigned as the
Companys Chief Financial Officer. An interim Chief Financial Officer was hired for the interim
period until James H. Mackaness was hired as full time Chief Financial Officer on January 2, 2008.
Key personnel, including certain members of our aesthetics sales force who joined the Company in
connection with the acquisition of the aesthetics business of Laserscope, have left the Company in
the past and there likely will be additional departures of key personnel from time to time
24
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future. The loss of any key employee could result in significant disruptions to our operations,
including adversely affecting the timeliness of product releases, the successful implementation and
completion of Company initiatives, and the results of our operations. Competition for these
individuals is intense, and we may not be able to attract, assimilate or retain highly qualified
personnel. Competition for qualified personnel in our industry and the San Francisco Bay Area, as
well as other geographic markets in which we recruit, is intense and characterized by increasing
salaries, which may increase our operating expenses or hinder our ability to recruit qualified
candidates. In addition, the integration of replacement personnel could be time consuming, may
cause additional disruptions to our operations, and may be unsuccessful.
If We Fail to Accurately Forecast Demand For Our Product and Component Requirements For the
Manufacture of Our Product, We Could Incur Additional Costs or Experience Manufacturing Delays and
May Experience Lost Sales or Significant Inventory Carrying Costs.
We use quarterly and annual forecasts based primarily on our anticipated product orders to
plan our manufacturing efforts and determine our requirements for components and materials. It is
very important that we accurately predict both the demand for our product and the lead times
required to obtain the necessary components and materials. Lead times for components vary
significantly and depend on numerous factors, including the specific supplier, the size of the
order, contract terms and current market demand for such components. If we overestimate the demand
for our product, we may have excess inventory, which would increase our costs. If we underestimate
demand for our product and, consequently, our component and materials requirements, we may have
inadequate inventory, which could interrupt our manufacturing, delay delivery of our product to our
customers and result in the loss of customer sales. Any of these occurrences would negatively
impact our business and operating results. During the fourth quarter of 2007, we received $3.7
million dollars in additional aesthetics inventory from American Medical Systems Holdings in
connection with the acquisition of the aesthetics business of Laserscope. At that time, with the
exception of some aesthetics products which are not being transferred to the Company, we assumed
primary responsibility for manufacturing the aesthetics product line that we acquired from
Laserscope and we will be integrating this operation into our current facility and manufacturing
organization. We may not have sufficient resources to assume these manufacturing obligations
without increased costs or delays and disruptions in manufacturing. Any of these occurrences would
negatively impact our business and operating results.
We Depend on Sole Source or Limited Source Suppliers.
We rely on third parties to manufacture substantially all of the components used in our
products, including optics, laser diodes and crystals. We have some long term or volume purchase
agreements with our suppliers and currently purchase components on a purchase order basis. Some of
our suppliers and manufacturers are sole or limited sources. In addition, some of these suppliers
are relatively small private companies that may discontinue their operations at any time. There are
risks associated with the use of independent manufacturers, including the following:
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unavailability of, shortages or limitations on the ability to obtain supplies of
components in the quantities that we require; |
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delays in delivery or failure of suppliers to deliver critical components on the dates
we require; |
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failure of suppliers to manufacture components to our specifications, and potentially
reduced quality; and |
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inability to obtain components at acceptable prices. |
Our business and operating results may suffer from the lack of alternative sources of supply
for critical sole and limited source components. The process of qualifying suppliers is complex,
requires extensive testing with our products, and may be lengthy, particularly as new products are
introduced. New suppliers would have to be educated in our production processes. In addition, the
use of alternate components may require design alterations to our products and additional product
testing under FDA and relevant foreign regulatory agency guidelines, which may delay sales and increase
product costs. In order to address our current liquidity issues, we have delayed the time period in
which we have made payments to our vendors that are the sources of our component supply without the
permission of such vendors. Any failures by our vendors to adequately supply limited and sole
source components may impair our ability to offer our existing products, delay the submission of
new products for regulatory approval and market introduction, materially harm our business and
financial condition and cause our stock price to decline. Establishing our own capabilities to
manufacture these components would be expensive and could significantly decrease our profit
margins. Our business, results of operations and financial condition would be adversely
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affected if
we are unable to continue to obtain components in the quantity and quality desired and at the
prices we have budgeted.
We Face Risks Associated with Our Collaborative and OEM Relationships.
Our collaborators may not pursue further development and commercialization of products
resulting from collaborations with us or may not devote sufficient resources to the marketing and
sale of such products. For example, in 2005 we developed and sold a laser system on an OEM basis
for a third party which positively impacted the revenues and gross margins during the second half
of 2005, but did not continue. We cannot provide assurance that these types of relationships will
continue over a longer period. Our reliance on others for clinical development, manufacturing and
distribution of our products may result in unforeseen problems. Further, our collaborative partners
may develop or pursue alternative technologies either on their own or in collaboration with others.
If a collaborator elects to terminate its agreement with us, our ability to develop, introduce,
market and sell the product may be significantly impaired and we may be forced to discontinue
altogether the product resulting from the collaboration. We may not be able to negotiate
alternative collaboration agreements on acceptable terms, if at all. The failure of any current or
future collaboration efforts could have a material adverse effect on our ability to introduce new
products or applications and therefore could have a material adverse effect on our business,
results of operations and financial condition.
We Depend on Collaborative Relationships to Develop, Introduce and Market New Products,
Product Enhancements and New Applications.
We depend on both clinical and commercial collaborative relationships. We entered into a
Product Supply Agreement with American Medical Systems Holdings (AMS) in connection with the
acquisition of the aesthetics business of Laserscope, pursuant to which American Medical Systems
Holdings currently manufacturers several of our aesthetics products. With the exception of some
service parts and the balance of finished goods ordered from AMS, we have transitioned the
manufacturing for the majority of these products to our facilities during the fourth quarter of
2007, but we may not have sufficient resources to assume these manufacturing obligations without
increased costs or delays and disruptions in manufacturing. We have entered into a Manufacture and
Supply Agreement with Synergetics, Inc. pursuant to which Synergetics will manufacture the
Companys line of adjustable laser probes, which represents one model of our disposable laser probe
offering. We have entered into collaborative relationships with academic medical centers and
physicians in connection with the research and innovation and clinical testing of our products.
Commercially, we currently collaborate with Bausch & Lomb to design and manufacture a solid-state
green wavelength (532nm) laser photocoagulator module for Bausch & Lomb, called the Millennium
Endolase module. The Millennium Endolase module is designed to be a component of Bausch & Lombs
ophthalmic surgical suite product offering and is not expected to be sold as a stand-alone product.
Sales of the Millennium Endolase module are dependent upon the actual order rate from and shipment
rate to Bausch & Lomb, which depends on the efforts of our partner and is beyond our control. We
cannot assure you that our relationship with Bausch & Lomb will result in further sales of our
Millennium Endolase module. The failure to obtain any additional future clinical or commercial
collaborations and the resulting failure or success of such arrangements of any current or future
clinical or commercial collaboration relationships could have a material adverse effect on our
ability to introduce new products or applications and therefore could have a material adverse
effect on our business, results of operations and financial condition.
If We Fail to Maintain Our Relationships With Health Care Providers, Customers May Not Buy Our
Products and Our Revenue and Profitability May Decline.
We market our products to numerous health care providers, including physicians, hospitals,
ambulatory surgical centers, government affiliated groups and group purchasing organizations. We
have developed and strive to maintain close relationships with members of each of these groups who
assist in product research and development and advise us on how to satisfy the full range of
surgeon and patient needs. We rely on these groups to recommend our products to their patients and
to other members of their organizations. The failure of our existing products and any new products
we may introduce to retain the support of these various groups could have a material adverse effect
on our business, financial condition and results of operations.
We Face Manufacturing Risks.
The manufacture of our infrared and visible laser consoles and the related delivery devices is
a highly complex and precise process. We assemble critical subassemblies and all of our final
products at our facility in Mountain View, California. We may experience manufacturing
difficulties, quality control issues or assembly constraints, particularly with regard to new
products that we may introduce. This transition occurred during the fourth quarter of 2007 and we
may not have sufficient resources to
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assume these manufacturing obligations without increased costs
or delays and disruptions in manufacturing. We may not be able to manufacture sufficient quantities
of our products, which may require that we qualify other manufacturers for our products.
Furthermore, we may experience delays, disruptions, capacity constraints or quality control
problems in our manufacturing operations and, as a result, product shipments to our customers could
be delayed, which would negatively impact our net revenues.
Our Operating Results May Fluctuate from Quarter to Quarter and Year to Year.
Our sales and operating results may vary significantly from quarter to quarter and from year
to year in the future. Our operating results are affected by a number of factors, many of which are
beyond our control. Factors contributing to these fluctuations include the following:
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general economic uncertainties and political concerns; |
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the timing of the introduction and market acceptance of new products, product
enhancements and new applications; |
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changes in demand for our existing line of ophthalmic and aesthetics products; |
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the cost and availability of components and subassemblies, including the willingness
and ability of our sole or limited source suppliers to timely deliver components at the
times and prices that we have planned; |
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our ability to maintain sales volumes at a level sufficient to cover fixed
manufacturing and operating costs; |
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fluctuations in our product mix between ophthalmic and aesthetics products and foreign
and domestic sales; |
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our ability to address our current liquidity issues; |
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the effect of regulatory approvals and changes in domestic and foreign regulatory
requirements; |
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introduction of new products, product enhancements and new applications by our
competitors, entry of new competitors into our markets, pricing pressures and other
competitive factors; |
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our long and highly variable sales cycle; |
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changes in the prices at which we can sell our products; |
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changes in customers or potential customers budgets as a result of, among other
things, reimbursement policies of government programs and private insurers for treatments
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increased product innovation costs. |
In addition to these factors, our quarterly results have been, and are expected to continue to
be, affected by seasonal factors.
Our expense levels are based, in part, on expected future sales. If sales levels in a
particular quarter do not meet expectations, we may be unable to adjust operating expenses quickly
enough to compensate for the shortfall of sales, and our results of operations may be adversely
affected. We encountered this adverse effect on our operating results in each of the quarters ended
March 31, 2007, June 30, 2007, September 29, 2007, December 29, 2007 and March 29, 2008. In
addition, we have historically made a significant portion of each quarters product shipments near
the end of the quarter. If that pattern continues, any delays in shipment of products could have a
material adverse effect on results of operations for such quarter. Due to these and other factors, we believe that quarter to quarter and year to year comparisons of
our past operating results may not be meaningful. You should not rely on our results for any
quarter or year as an indication of our future performance. Our operating results in future
quarters and years may be below expectations, which would likely cause the price of our common
stock to fall.
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Our Stock Price Has Been and May Continue to be Volatile and an Investment in Our Common Stock
Could Suffer a Decline in Value.
The trading price of our common stock has been subject to wide fluctuations in response to a
variety of factors, some of which are beyond our control, including quarterly variations in our
operating results, announcements by us or our competitors of new products or of significant
clinical achievements, changes in market valuations of other similar companies in our industry and
general market conditions. In addition, the trading price of our common stock has been
significantly adversely affected by our recent operation performance and by liquidity issues. In
the fiscal year ended December 29, 2007, the trading price of our common stock fluctuated from a
high of $10.70 per share to a low of $2.20 per share, and there can be no assurance our common
stock trading price will not suffer additional declines. From time to time, we meet with investors
and potential investors. In addition, we receive attention from securities analysts and present at
some analyst meetings. Our common stock may experience an imbalance between supply and demand
resulting from low trading volumes. These broad market fluctuations could have a significant impact
on the market price of our common stock regardless of our performance.
Material Increases in Interest Rates May Harm Our Sales.
Some of our products are sold to health care providers in general practice. Many of these
health care providers purchase our products with funds they secure through various financing
arrangements with third party financial institutions, including credit facilities and short-term
loans. If interest rates increase, these financing arrangements will be more expensive to our
customers, which would effectively increase the overall cost of owning our products for our
customers and, thereby, may decrease demand for our products. Any reduction in the sales of our
products would cause our business to suffer.
We Are Subject To Government Regulation Which May Cause Us to Delay or Withdraw the
Introduction of New Products or New Applications for Our Products.
The medical devices that we market and manufacture are subject to extensive regulation by the
FDA and by foreign and state governments. Under the Federal Food, Drug and Cosmetic Act and the
related regulations, the FDA regulates the design, development, clinical testing, manufacture,
labeling, sale, distribution and promotion of medical devices. Before a new device can be
introduced into the market, the product must undergo rigorous testing and an extensive regulatory
review process implemented by the FDA under federal law. Unless otherwise exempt, a device
manufacturer must obtain market clearance through either the 510(k) premarket notification process
or the lengthier premarket approval application (PMA) process. Depending upon the type, complexity
and novelty of the device and the nature of the disease or disorder to be treated, the FDA process
can take several years, require extensive clinical testing and result in significant expenditures.
Even if regulatory approval is obtained, later discovery of previously unknown safety issues may
result in restrictions on the product, including withdrawal of the product from the market. Other
countries also have extensive regulations regarding clinical trials and testing prior to new
product introductions. Our failure to obtain government approvals or any delays in receipt of such
approvals would have a material adverse effect on our business, results of operations and financial
condition.
The FDA imposes additional regulations on manufacturers of approved medical devices. We are
required to comply with the applicable Quality System regulations and our manufacturing facilities
are subject to ongoing periodic inspections by the FDA and corresponding state agencies, including
unannounced inspections, and must be licensed as part of the product approval process before being
utilized for commercial manufacturing. Noncompliance with the applicable requirements can result
in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total
or partial suspension of production, withdrawal of marketing approvals, and criminal prosecution.
The FDA also has the authority to request repair, replacement or refund of the cost of any device
we manufacture or distribute. Any of these actions by the FDA would materially and adversely affect
our ability to continue operating our business and the results of our operations.
In addition, we are also subject to varying product standards, packaging requirements,
labeling requirements, tariff regulations, duties and tax requirements. As a result of our sales in
Europe, we are required to have all products CE marked, an international symbol affixed to all
products demonstrating compliance with the European Medical Device Directive and all applicable
standards. While currently all of our released products are CE marked, continued certification is
based on the successful review of our quality system by our European Registrar during their annual audit.
Any loss of certification would have a material adverse effect on our business, results of
operations and financial condition.
If We Fail to Comply With the FDAs Quality System Regulation and Laser Performance Standards
Our Manufacturing Operations Could Be Halted, and Our Business Would Suffer.
We are currently required to demonstrate and maintain compliance with the FDAs Quality System
Regulation, or QSR. The QSR is a complex regulatory scheme that covers the methods and
documentation of the design, testing, control,
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manufacturing, labeling, quality assurance,
packaging, storage and shipping of our products. Because our products involve the use of lasers,
our products also are covered by a performance standard for lasers set forth in FDA regulations.
The laser performance standard imposes specific record-keeping, reporting, product testing and
product labeling requirements. These requirements include affixing warning labels to laser
products, as well as incorporating certain safety features in the design of laser products. The FDA
enforces the QSR and laser performance standards through periodic unannounced inspections. We have
been, and anticipate in the future being, subject to such inspections. Our failure to take
satisfactory corrective action in response to an adverse QSR inspection or our failure to comply
with applicable laser performance standards could result in enforcement actions, including a public
warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or
criminal penalties, or other sanctions, such as those described in the preceding paragraph, which
would cause our sales and business to suffer.
If We Modify One of Our FDA Approved Devices, We May Need to Seek Reapproval, Which, if Not
Granted, Would Prevent Us from Selling Our Modified Products or Cause Us to Redesign Our Products.
Any modifications to an FDA-cleared device that would significantly affect its safety or
effectiveness or that would constitute a major change in its intended use would require a new
510(k) clearance or possibly a pre-market approval. We may not be able to obtain additional 510(k)
clearance or pre-market approvals for new products or for modifications to, or additional
indications for, our existing products in a timely fashion, or at all. Delays in obtaining future
clearance would adversely affect our ability to introduce new or enhanced products in a timely
manner, which in turn would harm our revenue and future profitability. We have made modifications
to our devices in the past and may make additional modifications in the future that we believe do
not or will not require additional clearance or approvals. If the FDA disagrees, and requires new
clearances or approvals for the modifications, we may be required to recall and to stop marketing
the modified devices, which could harm our operating results and require us to redesign our
products.
The Requirements of Complying with the Sarbanes-Oxley Act of 2002 Might Strain Our Resources,
Which May Adversely Affect Our Business and Financial Condition.
We are subject to a number of requirements, including the reporting requirements of the
Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley Act of 2002. We are now
required to comply with certain requirements of Section 404 of the Sarbanes-Oxley Act which require
management to perform an assessment of internal control over financial reporting. These
requirements might place a strain on our systems and resources. The Sarbanes-Oxley Act requires,
among other things, that we maintain effective disclosure controls and procedures and internal
control over financial reporting. In order to maintain and improve the effectiveness of our
disclosure controls and procedures and internal control over financial reporting, significant
resources and management oversight will be required. As a result, our managements attention might
be diverted from other business concerns, which could have a material adverse effect on our
business, financial condition, and operating results. In addition, we might need to hire additional
accounting and financial staff with appropriate public company experience and technical accounting
knowledge, and we might not be able to do so in a timely fashion.
Because We Do Not Require Training for Users of Our Products, and Sell Our Products to
Non-physicians, There Exists an Increased Potential for Misuse of Our Products, Which Could Harm
Our Reputation and Our Business.
Federal regulations restrict the sale of our products to or on the order of licensed
practitioners. The definition of licensed practitioners varies from state to state. As a result,
our products may be purchased or operated by physicians with varying levels of training, and in
many states by non-physicians, including nurse practitioners and technicians. Outside the United
States, many jurisdictions do not require specific qualifications or training for purchasers or
operators of our products. We do not supervise the procedures performed with our products, nor do
we require that direct medical supervision occur. We, and our distributors, generally offer but do
not require purchasers or operators of our products to attend training sessions. In addition, we
sometimes sell our systems to companies that rent our systems to third parties and that provide a
technician to perform the procedure. The lack of training and the purchase and use of our products by
non-physicians may result in product misuse and adverse treatment outcomes, which could harm our
reputation and expose us to costly product liability litigation.
Some of Our Laser Systems Are Complex in Design and May Contain Defects That Are Not Detected
Until Deployed By Our Customers, Which Could Increase Our Costs and Reduce Our Revenues.
Laser systems are inherently complex in design and require ongoing regular maintenance. The
manufacture of our lasers, laser products and systems involves a highly complex and precise
process. As a result of the technical complexity of our products, changes in our or our suppliers
manufacturing processes or the inadvertent use of defective materials by us or our
29
suppliers could
result in a material adverse effect on our ability to achieve acceptable manufacturing yields and
product reliability. To the extent that we do not achieve such yields or product reliability, our
business, operating results, financial condition and customer relationships would be adversely
affected. We provide warranties on certain of our product sales, and allowances for estimated
warranty costs are recorded during the period of sale. The determination of such allowances
requires us to make estimates of failure rates and expected costs to repair or replace the products
under warranty. We currently establish warranty reserves based on historical warranty costs. If
actual return rates and/or repair and replacement costs differ significantly from our estimates,
adjustments to recognize additional cost of sales may be required in future periods.
Our customers may discover defects in our products after the products have been fully deployed
and operated under peak stress conditions. In addition, some of our products are combined with
products from other vendors, which may contain defects. As a result, should problems occur, it may
be difficult to identify the source of the problem. If we are unable to identify and fix defects or
other problems, we could experience, among other things:
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loss of customers; |
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increased costs of product returns and warranty expenses; |
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damage to our brand reputation; |
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failure to attract new customers or achieve market acceptance; |
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diversion of development and engineering resources; and |
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legal actions by our customers. |
The occurrence of any one or more of the foregoing factors could seriously harm our business,
financial condition and results of operations.
Our Products Could Be Subject to Recalls Even After Receiving FDA Approval or Clearance. A
Recall Would Harm Our Reputation and Adversely Affect Our Operating Results.
The FDA and similar governmental authorities in other countries in which we market and sell
our products have the authority to require the recall of our products in the event of material
deficiencies or defects in design or manufacture. A government mandated recall, or a voluntary
recall by us, could occur as a result of component failures, manufacturing errors or design
defects, including defects in labeling. A recall could divert managements attention, cause us to
incur significant expenses, harm our reputation with customers and negatively affect our future
sales.
If We Fail to Manage Growth Effectively, Our Business Could Be Disrupted Which Could Harm Our
Operating Results.
We have experienced and may in the future experience growth in our business, both organically
and through the acquisition of business and products. We have made and expect to continue to make
significant investments to enable our future growth through, among other things, new product
innovation and clinical trials for new applications and products. We must also be prepared to
expand our work force and to train, motivate and manage additional employees as the need for
additional personnel arises. Our personnel, systems, procedures and controls may not be adequate to
support our future operations. Any failure to effectively manage future growth could have a
material adverse effect on our business, results of operations and financial condition.
30
Our Manufacturing Capacity May Not Be Adequate to Meet the Demands of Our Business.
If our sales increase substantially, including increases in the sales of our aesthetics
products, we may need to increase our production capacity and may not be able to do so in a timely,
effective, or cost efficient manner. Any prolonged disruption in the operation of our manufacturing
facilities could materially harm our business. We cannot assure you that if we choose to scale-up
our manufacturing operations, we will have the resources necessary to do so, or that we will be
able to obtain regulatory approvals in a timely fashion, which could affect our ability to meet
product demand or result in additional costs.
If Product Liability Claims are Successfully Asserted Against Us, We may Incur Substantial
Liabilities That May Adversely Affect Our Business or Results of Operations.
We may be subject to product liability claims from time to time. Our products are highly
complex and some are used to treat extremely delicate eye tissue and skin conditions on and near a
patients face. We believe we maintain adequate levels of product liability insurance but product
liability insurance is expensive and we might not be able to obtain product liability insurance in
the future on acceptable terms or in sufficient amounts to protect us, if at all. A successful
claim brought against us in excess of our insurance coverage could have a material adverse effect
on our business, results of operations and financial condition.
Our Operating Results May be Adversely Affected by Changes in Third Party Coverage and
Reimbursement Policies and any Uncertainty Regarding Healthcare Reform Measures.
Our ophthalmology products are typically purchased by doctors, clinics, hospitals and other
users, which bill various third-party payers, such as governmental programs and private insurance
plans, for the health care services provided to their patients. Third-party payers are increasingly
scrutinizing and challenging the coverage of new products and the level of reimbursement for
covered products. Doctors, clinics, hospitals and other users of our products may not obtain
adequate reimbursement for use of our products from third-party payers. While we believe that the
laser procedures using our products have generally been reimbursed, payers may deny coverage and
reimbursement for our products if they determine that the device was not reasonable and necessary
for the purpose used, was investigational or was not cost-effective.
Changes in government legislation or regulation or in private third-party payers policies
toward reimbursement for procedures employing our products may prohibit adequate reimbursement.
There have been a number of legislative and regulatory proposals to change the healthcare system,
reduce the costs of healthcare and change medical reimbursement policies. Doctors, clinics,
hospitals and other users of our products may decline to purchase our products to the extent there
is uncertainty regarding reimbursement of medical procedures using our products and any healthcare
reform measures. Further proposed legislation, regulation and policy changes affecting third party
reimbursement are likely. We are unable to predict what legislation or regulation, if any, relating
to the health care industry or third-party coverage and reimbursement may be enacted in the future,
or what effect such legislation or regulation may have on us. However, denial of coverage and
reimbursement of our products would have a material adverse effect on our business, results of
operations and financial condition.
If Our Facilities Were To Experience Catastrophic Loss, Our Operations Would Be Seriously
Harmed.
Our facilities could be subject to catastrophic loss such as fire, flood or earthquake. All of
our research and development activities, manufacturing, our corporate headquarters and other
critical business operations are located near major earthquake faults in Mountain View, California.
Any such loss at any of our facilities could disrupt our operations, delay production, shipments
and revenue and result in large expense to repair and replace our facilities.
Our Business is Subject to Environmental Regulations.
Our facilities and operations are subject to federal, state and local environmental and
occupational health and safety requirements of the United States and foreign countries, including
those relating to discharges of substances to the air, water and land, the handling, storage and
disposal of hazardous materials and wastes and the cleanup of properties affected by pollutants.
Failure to maintain compliance with these regulations could have a material adverse effect on our
business or financial condition.
In the future, federal, state or local governments in the United States or foreign countries
could enact new or more stringent laws or issue new or more stringent regulations concerning
environmental and worker health and safety matters that
31
could affect our operations. Also, in the
future, contamination may be found to exist at our current or former facilities or off-site
locations where we have sent wastes. We could be held liable for such newly discovered
contamination which could have a material adverse effect on our business or financial condition. In
addition, changes in environmental and worker health and safety requirements could have a material
adverse effect on our business or financial condition.
Our Export Controls May Not be Adequate to Ensure Compliance With United States Export Laws,
Especially When We Sell Our Products to Distributors Over Which We Have Limited Control.
The United States government has declared an embargo that restricts the export of products and
services to a number of countries, including Iran, Syria, Sudan and Cuba, for a variety of reasons,
including the support by these countries of terrorism. We sell our products through distributors in
Europe, Asia and the Middle East, and in such circumstances the distributor is responsible for
interacting with the end user of our products, including assisting in the set up of any products
purchased by such end user. In order to comply with United States export laws, we have instituted
export controls including training for our personnel in export restrictions and requirements,
appointing an export control officer to oversee our export procedures, executing agreements with
our distributors that include defining their territory for sale and requirements pertaining to
United States export laws, obtaining end user information from our distributors and screening it to
restricted party lists maintained by the United States government. While we believe that these
procedures are adequate to prevent the export or re-export of our products into countries under
embargo by the United States government, we cannot assure you that our products will not be
exported or re-exported by our distributors into such restricted countries. In particular, our
control over what our distributors do with our products is necessarily limited, and we cannot
assure you that they will not sell our products to an end user in a country in violation of United
States export laws. Any violation of United States export regulations could result in substantial
legal, consulting and accounting costs, and significant fines and/or criminal penalties. In the
event that our products are exported to countries under a United States trade embargo in violation
of applicable United States export laws and regulations, such violations, costs and penalties or
other actions that could be taken against us could adversely affect our reputation and/or have an
adverse effect on our business, financial condition, prospects or results of operations.
We have sold and may continue to sell, with a license, our products into countries that are
under embargo by the United States and as a result have incurred and may continue to incur
significant legal, consulting and accounting fees and may place our Companys reputation at risk.
United States export laws permit the sale of medical products to certain countries under
embargo by the United States government if the seller of such products obtains a license to do so,
which requirements are in place because the United States has designated such countries as state
sponsors of terrorism. Certain of our products have been sold in Iran, Sudan and Syria under
license through distribution agreements with independent distributors. The aggregate revenue
generated by sales of our products into Iran, Sudan and Syria have been immaterial to our business
and results of operations.
We may continue to supply medical devices to Iran, Sudan and Syria and other countries that
are under embargo by the United States government upon obtaining all necessary licenses. We do not
believe, however, that our sales into such countries will be material to our business or results of
operations. There are risks we face in selling to countries under United States embargo, including,
but not limited to, possible damage to our reputation for sales to countries that are deemed to
support terrorism, and failure of our export controls to limit sales strictly to the terms of the
relevant license, which failure may result in civil and criminal penalties. In addition, we may
incur significant legal, consulting and accounting costs in ensuring compliance with our export
licenses to countries under embargo. Any damage to our reputation from such sales, failure to
comply with the terms of our export licenses or the additional costs we incur in making such sales
could have a material adverse impact on our business, financial condition, prospects or results of
operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
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Item 5. Other Information
None.
Item 6. Exhibits
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10.1
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Change of Control Severance Agreement by and between the Company and James Mackaness, dated January 22,
2008 (described more fully in the Companys Current Report on Form 8-K filed with the Securities and
Exchange Commission on January 28, 2008 and incorporated herein by reference). |
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10.2
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Separation Agreement by and between the Company and Larry Tannenbaum, dated January 22, 2008 (described
more fully in the Companys Current Report on Form 8-K filed with the Securities and Exchange Commission
on January 28, 2008 and incorporated herein by reference). |
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10.3
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Credit and Security Agreement by and between IRIDEX Corporation and Wells Fargo Bank, National
Association, acting through its Wells Fargo Business Credit operating division, dated March 27, 2008
(which is incorporated herein by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K
(Commission File No. 000-27598) filed on April 2, 2008). |
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10.4
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Credit and Security Agreement (Ex-Im Subfacility) by and between IRIDEX Corporation and Wells Fargo Bank,
National Association, acting through its Wells Fargo Business Credit operating division, dated March 27,
2008 (which is incorporated herein by reference to Exhibit 10.2 to the Registrants Current Report on Form
8-K (Commission File No. 000-27598) filed on April 2, 2008). |
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10.5
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Borrower Agreement by IRIDEX Corporation in favor of Export-Import Bank of the United States and Wells
Fargo Bank, National Association, acting through its Wells Fargo Business Credit operating division, dated
March 27, 2008 (which is incorporated herein by reference to Exhibit 10.3 to the Registrants Current
Report on Form 8-K (Commission File No. 000-27598) filed on April 2, 2008). |
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31.1
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Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a). |
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31.2
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Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a). |
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32.1
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Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2
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Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
33
Trademark Acknowledgments
IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, SmartKey, EndoProbe, Apex, Aura, Lyra,
Gemini, Venus, Coolspot and Dermastat are our registered trademarks. G-Probe, DioPexy, DioVet,
TruFocus, TrueCW, DioLite, IQ 810, MicroPulse, OtoProbe, ScanLite, Symphony, VariLite and EasyFit
product names are our trademarks. All other trademarks or trade names appearing in this Annual
Report on Form 10-K are the property of their respective owners.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IRIDEX Corporation (Registrant)
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Date: May 13, 2008 |
By: |
/s/ THEODORE A. BOUTACOFF
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Name: |
Theodore A. Boutacoff |
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Title: |
President and Chief Executive Officer
(Principal Executive and Principal
Financial Officer) |
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Index
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10.1
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Change of Control Severance Agreement by and between the Company and James Mackaness, dated January 22,
2008 (described more fully in the Companys Current Report on Form 8-K filed with the Securities and
Exchange Commission on January 28, 2008 and incorporated herein by reference). |
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10.2
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Separation Agreement by and between the Company and Larry Tannenbaum, dated January 22, 2008 (described
more fully in the Companys Current Report on Form 8-K filed with the Securities and Exchange Commission
on January 28, 2008 and incorporated herein by reference). |
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10.3
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Credit and Security Agreement by and between IRIDEX Corporation and Wells Fargo Bank, National
Association, acting through its Wells Fargo Business Credit operating division, dated March 27, 2008
(which is incorporated herein by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K
(Commission File No. 000-27598) filed on April 2, 2008). |
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10.4
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Credit and Security Agreement (Ex-Im Subfacility) by and between IRIDEX Corporation and Wells Fargo Bank,
National Association, acting through its Wells Fargo Business Credit operating division, dated March 27,
2008 (which is incorporated herein by reference to Exhibit 10.2 to the Registrants Current Report on Form
8-K (Commission File No. 000-27598) filed on April 2, 2008). |
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10.5
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Borrower Agreement by IRIDEX Corporation in favor of Export-Import Bank of the United States and Wells
Fargo Bank, National Association, acting through its Wells Fargo Business Credit operating division, dated
March 27, 2008 (which is incorporated herein by reference to Exhibit 10.3 to the Registrants Current
Report on Form 8-K (Commission File No. 000-27598) filed on April 2, 2008). |
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31.1
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Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a). |
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31.2
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Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a). |
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32.1
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Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2
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Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |